Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT01061957
Eligibility Criteria:
Inclusion Criteria:
* Raltegravir cohort patients: From the Danish HIV Cohort Study (DHCS) we included all HIV-1 positive patients, who
1. started raltegravir after 1 January 2006 and before 1 July 2009,
2. had been treated with HAART previously
3. had at least two VL tests done prior to initiation of raltegravir treatment,
4. had virological failure prior to start of raltegravir and
5. did not participate in randomized clinical trials on raltegravir. Virological failure was defined as VL \> 500 copies/ml in the two latest VL tests prior to raltegravir initiation while on HAART treatment.
* Control cohort patients: From DHCS we identified a control cohort of HIV infected patients who started HAART for the first time after 1 January 2006 and before 1 July 2009. From this population we extracted two control patients for each raltegravir patient, each matched by gender, race (Caucasian, Black and other), route of HIV infection (homosexual, heterosexual, injection drug user (IDU) and other) and age (intervals of \< 20 years, 20 to 30 years, 30 to 40 years, \> 50 years).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01061957
Study Brief:
Protocol Section:
NCT01061957